From Zuckerman: New study on platinum in breast milk of silicone implant patients

[Guest guest]

--- Zuckerman <dz@...> wrote:

> From: " Zuckerman " <dz@...>

> <ifriendsA@...>

> Subject: new study on platinum in breast milk of

> silicone implant patients

> Date: Sun, 9 Apr 2006 13:07:29 -0400

>

> Dear Friends,

>

> This is the article on platinum in breast milk and

> other body fluids that was published online a few

> days ago, and will be published in the journal

> Analytical Chemistry on May 1. A simplified summary

> by CANDO is below.

>

>

> At the FDA advisory panel meeting on silicone

> implants last April, several patients testified

> about platinum in their bodies from breast implants.

> When advisory panel members asked Inamed on April

> 12 about platinum in implants, they were assured by

> Dr. Brook (an Inamed consultant) that the platinum

> was in the " zero valent state " and therefore safe.

> Similarly, on April 13, Mentor's Dr. told the

> panel that the platinum " as far as we can tell " is

> 100 percent at the zero valent state. The

> transcripts are available online at

>

http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4101t2.DOC

> and at

>

http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4101t3.doc

>

>

>

> However, this newly published peer-reviewed study

> finds that in women with silicone implants, there

> were very high levels of platinum in their breast

> milk, urine, hair and nails, and that the platinum

> was in the +2, +4, and +6 oxidation states, rather

> than 0. In contrast, the two women tested with

> saline breast implants did not have elevated

> platinum in their body fluids.

>

>

>

> Since most women who get breast augmentation are

> reproductive age, and they are currently advised

> that implants do not interfere with breastfeeding,

> this is potentially very big news that should have

> an impact on FDA's approval process.

>

>

>

> Please note that this does not mean that all women

> with breast implants have platinum in their bodies.

> It means that we need more information about how

> often this happens and what the health effects are.

>

>

>

> The 2005 statistics of the American Society for

> Aesthetic Plastic Surgery estimates that 58,000

> augmentation patients (not reconstruction patients)

> received silicone gel breast implants in the U.S.

> last year.

>

>

>

> Congratulations to Keeling, Maharaj,

> and Ernest Lykissa on this important research!

>

>

>

> Best wishes,

>

>

>

> Zuckerman, Ph.D.

>

> President

>

> National Research Center for Women & Families

>

> 1701 K Street, NW, Ste. 700

>

> Washington, DC 20006

>

> (202) 223-4000

>

> www.center4research.org

>

>

>

>

>

> Summary of Research

>

> Total Platinum Concentration and Platinum Oxidation

> States in

>

> Body Fluids, Tissue, and Explants from Women Exposed

>

> To Silicone and Saline Breast Implants by IC-ICP-MS

>

> E.D. Lykissa and S.V.M. Maharaj

>

> in

>

> Analytical Chemistry, April 2006

>

>

>

> Summary

>

>

>

> Women exposed to silicone breast implants have

> platinum levels that exceed that of the general

> population, and the oxidation states of the platinum

> indicate that the exposure may be toxic.

>

>

>

> Ion chromatography-inductively coupled plasma-mass

> spectrometry (IC-ICP-MS) was used to determine the

> total platinum (Pt) concentration and platinum

> oxidation states in samples from women exposed to

> silicone and saline breast implants. Samples

> included: whole blood, urine, hair, nails, sweat,

> brain tissue, breast milk, and explants.

>

>

>

> Platinum in nine explanted silicone gel breast

> implants were mainly in the +2, +4, and +6 oxidation

> states. Platinum in seven whole blood and six

> breast milk samples from women implanted with

> silicone breast implants occurred mainly in the +2

> and +4 oxidation states. In contrast, the fluid

> from the two saline breast explants tested did not

> contain detectable levels of Pt.

>

>

>

> This peer-reviewed published study is the first to

> document the various platinum oxidation states in

> samples from women exposed to silicone breast

> implants. Positive oxidation states indicate risk.

>

>

>

> Introduction

>

>

>

> A complex platinum salt, hexachloroplatinate, has

> been used in silicone gel-filled breast implants as

> a catalyst in both the gel and envelope. Platinum

> salt exposure has been associated with a range of

> problems, from positive skin-patch tests (indicating

> an allergic reaction) and contact dermatitis, to

> more serious problems such as asthma,

> immunogenicity, and including potentially fatal

> reactions such as inhibitory effects on brain

> enzymes, neurotoxicity, mutagenicity,

> carcinogenicity, and allergic anaphylactic

> reactions.

>

>

>

> Recent studies have shown that there are significant

> amounts of platinum in silicone breast implant gel

> and envelopes. Platinum has been shown to leak out

> of intact implants, and accumulate in the scar

> tissue and breast tissue of women exposed to

> silicone breast implants.

>

>

>

> Platinum in compounds that occur in oxidation states

> other than zero (0) may be harmful to human health.

> In the compound hexachloroplatinate (used in

> silicone gel-filled breast implants), the oxidation

> state of platinum is +4. No previous study ever

> actually analyzed a breast implant or explant for

> the various forms of platinum.

>

>

>

> Materials and Methods

>

>

>

> The average amount of time the implants were in the

> women's bodies was approximately fourteen years.

> The number of years the subjects were explanted

> before the analyses were conducted was six years.

>

>

>

> The surgically explanted silicone implants in this

> study were all 2nd generation implants, from the

> 1970s-1980's, except for one more recent (3rd

> generation), " low-bleed " silicone gel breast

> implant.

>

>

>

> Questionnaires were completed to provide information

> regarding whether the women had been treated with

> platinum-based chemotherapy drugs; had worked in

> occupational settings where exposure to platinum may

> have occurred; or had dental amalgams that contained

> platinum.

>

>

>

> Results and Discussion

>

>

>

> The average platinum concentration in samples from

> women exposed to silicone breast implants was found

> to be the following when compared to samples from

> individuals with no known platinum exposure:

>

> Hair samples 14 times

> higher

>

> Nail samples 3 times

> higher

>

> Breast Milk 100 times

> higher

>

> Urine 60-1700

> times higher

>

>

>

> Our results indicate that platinum migrates from

> silicone implants via the lymphatic and blood

> systems into the urine, sweat, and breast milk, with

> deposits and accumulation in hair and nails.

> Platinum, including ionized forms of platinum, may

> persist years after the silicone gel breast implants

> have been removed.

>

>

>

> The women did not have other platinum exposures that

> could explain the results.

>

>

>

> All silicone envelopes used in silicone- and saline

> breast implants (and in testicular implants

> catalyzed with ionized platinum) would be expected

> to degrade and depolymerize as they age.

>

> Conclusion

>

>

>

> Silicone gel breast implants are the most likely

> source of the elevated total platinum levels, and

> the reactive forms of platinum in women

>

>

>

>

>

>

>